Deputy Technical Director of Quality

Position: Deputy Technical Director of Quality

Experience: 5+ years in leadership roles within pharmaceutical FDF manufacturing

Want to know more?

BioNanoPharma is a global company committed to excellence across the pharmaceutical value chain, bringing innovation, quality, and expertise in research, development, manufacturing, and distribution of pharmaceutical products. Our mission is to improve health and well-being through advanced and sustainable solutions.

Ready to be a #Challenger?

What are we looking for?

As Deputy Technical Director of Quality, you will:

• Develop, implement, and maintain the Quality Management System (QMS) in line with industry standards.
• Manage quality documentation: SOPs, work instructions, and other key documents.
• Plan and execute internal and external audits, ensuring readiness for regulatory and client inspections.
• Ensure compliance with regulations (GDP, GMP, FDA, and other applicable standards).
• Oversee the acquisition and maintenance of required certifications and licenses.
• Identify and mitigate compliance risks across the supply chain.
• Conduct regular warehouse inspections, ensuring optimal storage and handling conditions, especially for temperature-sensitive products.
• Implement quality controls in inventory management and freight forwarding operations.
• Investigate incidents and manage corrective and preventive actions (CAPAs).
• Lead continuous improvement initiatives using Lean/Six Sigma methodologies.
• Define and monitor quality and operational efficiency KPIs.
• Foster a culture of quality and accountability throughout the organization.
• Design and deliver training programs on quality standards and compliance.
• Collaborate with operations, logistics, and customer service teams to align quality objectives.
• Address and resolve customer complaints, conduct root cause analysis, and implement corrective actions.
• Report to senior management on quality performance and areas for improvement.
• Act as a substitute for the Technical Director of Quality when required, ensuring continuity of leadership and quality standards.
• Perform QP activities and oversee batch release for clinical trial products.

The challenge! 🚀

• Supervise and maintain compliant operations for the certification of Investigational Medicinal Product batches.
• Stay up to date with legislative changes relevant to QP Certification and propose compliance actions.
• Align quality policies with the Insud Pharma Corporate Quality System.
• Influence and lead cross-functional teams towards operational excellence and customer satisfaction.

What do you need? 🤓

• Bachelor’s degree in Pharmacy, Medicine, Veterinary Medicine, Chemistry, Pharmaceutical Chemistry and Technology, or Biology.
• At least 5 years of experience in a leadership role at a pharmaceutical FDF manufacturing site.
• Experience with FDA regulations is highly valued.
• Quality-related certifications (ISO 9001 Lead Auditor, Six Sigma Black Belt, GDP Certification) are highly desirable.
• Fluent in Spanish and English.
• Strong leadership, communication, analytical, and stakeholder management skills.

⏰ Flexible working hours

Professional development and continuous training

What’s the selection process like? ️

• Initial contact by phone or email.
• 1 or 2 interviews (on-site/virtual) with HR and the Technical Management team.
• Ongoing communication about your application status.

Not the right fit for you?

Follow us on LinkedIn and Instagram to stay updated on future job opportunities. #BioNanoPharma #Challenger #InsudTalent

COMMITMENT TO EQUAL OPPORTUNITIES

At BioNanoPharma, we promote gender equality and do not discriminate based on ethnicity, religion, sexual orientation, disability, or any other factor. We believe in a diverse, inclusive, and respectful workplace for everyone.

#J-18808-Ljbffr